Registry of Patients Undergoing Endoscopic Management of Pancreatic Fluid Collections
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Endoscopic management of pancreatic fluid collections.
- Кому может быть актуально
- Состояния в реестре: Acute Pancreatitis, Pancreatic Pseudocyst, Pancreatic Necrosis. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
Acute pancreatitis is one of the most common gastrointestinal disorders requiring hospitalization worldwide. Pancreatic fluid collections can occur as a consequence of acute and chronic pancreatitis and can result in significant morbidity and mortality, including significant abdominal pain, gastric outlet obstruction, biliary obstruction, organ failure, persistent unwellness, infection and sepsis. Symptomatic pancreatic fluid collections require treatment, and endoscopic drainage is considered standard of care. The aim of this study is to evaluate the treatment outcomes in patients undergoing standard of care, endoscopic treatment of pancreatic fluid collections.
Подробное описание
Acute pancreatitis has an annual incidence of 13-45 cases per 100,000 persons and is one of the most common gastrointestinal disorders requiring hospitalization worldwide. It leads to over a quarter of a million hospital admissions annually in the United States, and inpatient costs exceeding 2.5 billion US dollars. Pancreatic fluid collections can occur as a consequence of acute and chronic pancreatitis and can result in significant morbidity and mortality, including significant abdominal pain, gastric outlet obstruction, biliary obstruction, organ failure, persistent unwellness, infection and sepsis.
Symptomatic pancreatic fluid collections require treatment, and endoscopic drainage is considered standard of care. Endoscopic treatment involves the drainage of the fluid collection into the stomach or duodenum by placement of metal or plastic stents. If clinically indicated, endoscopic necrosectomy is also performed, which is the removal of devitalized pancreatic tissue using the endoscope. Currently the treatment success rate of endoscopic treatment of pancreatic fluid collections exceeds 90%.
The aim of this study is to evaluate the treatment outcomes in patients undergoing standard of care, endoscopic treatment of pancreatic fluid collections.
Вмешательства
- Процедура Endoscopic management of pancreatic fluid collections
Patients with pancreatic fluid collections will be undergoing EUS-guided drainage and/or endoscopic necrosectomy
Первичные конечные точки
- Treatment outcomes in patients undergoing endoscopic treatment of pancreatic fluid collections according to timing of treatment. [Срок оценки: 6 months]
Вторичные конечные точки (12)
- Treatment success [Срок оценки: 6 months]
- Number and type of interventions performed [Срок оценки: 6 months]
- Need for surgical intervention [Срок оценки: 6 months]
- Technical success of endoscopic interventions in pancreatic fluid collections. [Срок оценки: 6 months]
- Inflammatory response and organ failure in patients undergoing endoscopic therapy for pancreatic fluid collections. [Срок оценки: 6 months]
- Disease-related adverse events [Срок оценки: 6 monthts]
- Procedure-related adverse events [Срок оценки: 6 months]
- Timing of intervention [Срок оценки: 6 months]
- Hounsfield units of the pancreatic fluid collection [Срок оценки: 6 months]
- Impact of partial versus full encapsulation of pancreatic fluid collections [Срок оценки: 6 months]
- Incidence of disconnected pancreatic duct syndrome and sequelae of disconnected pancreatic duct syndrome [Срок оценки: 6 months]
- Hospital admission [Срок оценки: 6 months]
Критерии участия
Критерии включения
- Age ≥ 18 years
- All patients undergoing endoscopic treatment of pancreatic fluid collections
Критерии исключения
- Age < 18 years
- Patients who did not receive endoscopic treatment of pancreatic fluid collections
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
США · 1 центр
- Orlando Health — Orlando
Идентификаторы
NCT: NCT06179459 · 22.060.03